I wrote previously on the apparent I wrote previously on the apparent scientific basis for the differing opinions of Judge Lourie and Judge Bryson on the patent-eligibility of isolated genomic DNA claims in Association for Molecular Pathology v. USPTO. Here, I look at Judge Moore's concurring opinion, which appears to agree in principal with Judge Bryson's legal analysis, but places more emphasis on policy concerns to reach agreement with Judge Lourie.
Judge Moore's Concurrence
While Judge Moore concurred in the decision that "isolated DNA" claims are eligible for patent protection under 35 USC § 101, she did not agree with Judge Lourie's "breaking covalent bonds" test. She wrote separately to explain why she reached the same decision, and how she might decide similar issues in future cases.
Flexible, Case-By-Case Determination
Judge Moore reads Supreme Court precedent such as Funk Brothers and Chakrabarty as indicating that patent-eligibility should be assessed on a case-by-case basis, without categorically approving or disapproving certain subject matter. She reads both cases as setting forth flexible frameworks for applying § 101:
Funk Brothers indicates that an invention which "serve[s] the ends nature originally provided" is likely unpatentable subject matter, but an invention that is an "enlargement of the range of . . . utility" as compared to nature may be patentable.
Chakrabarty illustrates that an invention with a distinctive name, character, and use, e.g., markedly different characteristics with the potential for significant utility, is patentable subject matter.
Thus, Judge Moore believes that the appropriate analysis under § 101 is whether the claimed subject mater has "markedly different characteristics with the potential for significant utility, e.g., an 'enlargement of the range of . . . utility' as compared to nature."
Importance Of A New Utility
While Judge Moore agreed with Judge Lourie that the structural differences between isolated DNA sequences and genomic DNA as it exists in nature (e.g., as part of a chromosome) are important, she did not agree that "this difference alone necessarily makes isolated DNA so 'markedly different' as to support patent-eligibility. Rather, she would add a second step to the analysis and "consider whether these [structural] differences impart a new utility which makes the molecules markedly different from nature."
(Judge Moore appears to agree with Judge Bryson on this point, as he also would consider both the structural and functional similarities between a species as "isolated" versus as it exists in nature.)
With regard to claims reciting short segments of isolated DNA (such as 15 nucleotide bases), Judge Moore noted that they are useful in many applications where naturally occurring DNA is not, such as as primers and probes. Additionally, Judge Moore believes that "[t]he ability to use isolated DNA molecules as the basis for diagnostic genetic testing is clearly an 'enlargement of the range of . . . utility' as compared to nature," because "[t]he same sequence, as it appears in nature as part of the chromosome, simply cannot be used in the same way." Thus she believes that "small, isolated DNA fragments are patentable subject matter" because "the different chemical structure of the isolated DNA, which is a product of the intervention of man, leads to a different and beneficial utility."
Policy Reasons Support Decision On Claims Encompassing Isolated, Genomic DNA
Applying her own test to claims encompassing isolated, genomic DNA, Judge Moore expresses doubts as to their patent-eligibility:
If I were deciding this case on a blank canvas, I might conclude that an isolated DNA sequence that includes most or all of a gene is not patentable subject matter. Despite the literal chemical difference, the isolated full length gene does not clearly have a new utility and appears to simply serve the same ends devised by nature, namely to act as a gene encoding a protein sequence.
Still, she finds them to satisfy § 101 for policy reasons.
- Congress has, for centuries, authorized an expansive scope of patentable subject matter.
- [T]he United States Patent Office has allowed patents on isolated DNA sequences for decades, and, more generally, has allowed patents on purified natural products for centuries.
- The settled expectations of the biotechnology industry—not to mention the thousands of issued patents—cannot be taken lightly and deserve deference.
Judge Moore has too many concerns about disrupting "[t]he settled expectations of the inventing community with respect to isolated DNA claims," and does not find that Supreme Court cases like Funk Brothers or Chakrabarty mandate such a potentially far-reaching result.
Responding to Judge Bryson's dissenting views that "this may well be one of those instances in which 'too much patent protection can impede rather than "promote the Progress of Science and useful Arts,"'" Judge Moore points out that "the biotechnology industry is among our most innovative, and isolated gene patents, including the patents in suit, have existed for decades with no evidence of ill effects on innovation."
(I imagine that those who disagree would raise the possibility that even more innovation would have occurred without gene patents, but I will leave that debate to others!)
Moore's Criticism of DOJ's Magic Microscope Test
Like Judge Lourie, Judge Moore found much to criticize about the Department of Justice's "magic microscope" test:
Certainly the magic microscope has curb appeal—its child-like simplicity an apparent virtue. The magic microscope, however, would not see the claimed DNA molecules at issue in this case. An isolated DNA molecule has different chemical bonds as compared to the “unisolated” sequence in the chromosome (the ends are different). In short, the claimed molecules cannot be seen in nature through the magic microscope. While you may be able to see the order of DNA nucleotides in the chromosome, the isolated fragment of DNA is a different molecule.
Judge Moore also criticizes the "magic microscope" test for creating a "bright line rule" which she finds inconsistent with "Chakrabarty’s flexible inquiry," and for being inconsistent with the holding in Funk Brothers, where the claimed combination of microorganisms was "not actually present in nature."
Judge Moore Passes The Baton To Congress
Judge Moore cites congressional inaction on this issue as a further reason for maintaining the status quo, but invites Congress to weigh in:
The patents in this case might well deserve to be excluded from the patent system, but that is a debate for Congress to resolve. I therefore decline to extend the "laws of nature" exception to include isolated DNA sequences.
One Holding, Two Rationales
While Judge Moore concurs with Judge Lourie on the patent-eligibility of "isolated DNA" claims generally, very different reasons led to her conclusions on the fragment claims versus the full-length, genomic DNA claims. She believes that the fragment claims are patent-eligible under Supreme Court jurisprudence (applying a test similar to that used by Judge Bryson), but offers only policy reasons for sustaining the full-length, genomic claims under § 101. In my mind, this indicates that her decision on the genomic DNA claims rests on shaky ground, and might be subject to dissuasion based on countervailing policy concerns.